A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG
- Patients must give written (personally signed and dated) informed consent before
completing any study related procedure.
- Patients must be 18 years old or over.
- Patients must have a documented diagnosis of locally advanced or metastatic prostate
cancer suitable for hormonal treatment
- Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL
- Patients must have received at least two injections of a 3- monthly LHRH agonist by
the time of the screening tests
- Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels
between screening and baseline (i.e. the baseline value must either be lower or less
than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the
- For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any
formulation) must have been initiated within the last 3 years from Baseline,
- For patients with metastatic prostate cancer (M+) and a Gleason score
≤ 7, LHRH agonist injection (any formulation) must have been initiated within the
last 2 years from Baseline,
- For patients with metastatic prostate cancer (M+) and a Gleason score > 7, LHRH
agonist injection (any formulation) must have been initiated within the last 12
months from Baseline.
- Patients must have an estimated life expectancy of at least twelve months according
to the investigator's assessment.
- Patients will not be included in the study if:
- Patients have had previous surgical castration.
- Patients are, in the opinion of the investigator, unable to comply fully with the
protocol and the study instructions.
- Patients have received investigational drug(s) or treatment(s) within 30 days prior
to study entry or will require a concurrent treatment with any other experimental
drugs or treatments.
- Patients have had a diagnosis of any other cancer without a history of
stability/remission within five years of screening, with the exception of
non-metastatic basal cell carcinoma.
- Patients currently taking additional anti-androgen therapy as part of an active
hormonal control therapy.
- Patients scheduled to receive palliative radiotherapy during the course of the study.
- Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to
- Patients receiving LHRH agonist as adjuvant to surgery.
- Patients scheduled to undergo radical prostatectomy during the course of the study.
- Patients with known hypersensitivity to LHRH agonists, their analogues or any or any
other component of the products to be administered.